The nose is a complex organ with connections to the respiratory tract and the central nervous system. The nose has a nose cavity open to the face at the anterior nares (nostrils) and extending posteriorly to the pharynx. The interior surface area of the nose is increased by the presence of multiple nasal turbinates, which are structures on the side walls of the inside of the nose having a cross-section that represents fine tear shapes hanging within the nasal cavity. The nasal turbinates include a superior turbinate, a middle turbinate and an inferior turbinate. Also included in the nasal cavity are olfactory bulbs and olfactory nerves for the sense of smell. The nasal cavity is also connected to and continuous with the paranasal sinuses or passages. The paranasal sinuses are located generally behind the forehead and cheekbones. The principal nasal sinuses are a frontal sinus, a sphenoidal sinus, a maxillary sinus and an ethmoid sinus. The nasal cavity and the paranasal sinuses are lined generally throughout with a ciliated mucous membrane. The orifice of the auditory or Eustachian canal to the ear is located at the posterior of the nasal cavity.
Part of the function of the nose is to provide pre-warming and humidification of inhaled air as well as some heat recovery and moisture recovery of air exhaled from the lungs. In addition, particulate filtering and smelling of the air is also performed by the nose with the sense of smell also contributing to the sense of taste. The nose also contributes to the speech faculty. The mucous secreting membrane together with the cilia performs a filtering function and a mucosal-ciliary transport system for the filtered material. The amount of mucous being secreted in 24 hours can be up to 1 liter. Mucous membranes of the nasal cavity and paranasal sinuses can more than double their secretion when inflamed or stimulated. The mucous is also one of the first lines of immune defense due to the presence of immunoglobulins within the mucous. The blood supply, local membrane responses, autonomic nerves and the central nervous system contribute to the level of control of mucous secretion and swelling of the nasal membranes. Furthermore, the membranes of the nose and paranasal sinuses are highly vascular, such that compounds absorbed by the membranes can be readily transported to the blood vessels of the nose and paranasal sinuses and subsequently to the rest of the body by the circulatory system.
Nasal congestion can be defined as the blockage of the nasal passages and paranasal sinuses usually from the swelling of membranes lining the nose due to vasodilatation of local blood vessels and/or inflammation of the membranes. Nasal congestion can also be referred to as nasal blockage, nasal obstruction, blocked nose, stuffy nose or stuffed up nose. Nasal congestion can have many multi-factorial causes and can range from a mild annoyance to a life-threatening condition.
For example, nasal congestion can interfere with hearing and consequently delay speech development in young children. In children and adults, nasal congestion can interfere with sleep, contribute to snoring, and is sometimes associated with sleep apnea. In general nasal congestion, can also cause, or is associated with postnasal drainage, facial pressure and pain, headaches, chronic or recurrent sinusitis and sinus infections. Other associated effects of nasal congestion in a general order of frequency include: dripping of mucous membrane secretions down the throat, abnormal taste sensations, feelings of dryness in the upper respiratory tract, drowsiness, nasal irritation, loss of the sense of smell, and burning sensations within the nose and nose bleeds. Co-morbidity conditions are often overlooked, but can contribute significantly to the burden of nasal congestion and allergic rhinitis (AR) for a patient. Examples of co-morbidity conditions reported in a significant number of patients include asthma, nasal polyps (nasal polyposis) and sleep apnea. Nasal congestion in an infant in the first few months of life can interfere with breast feeding and in severe cases can cause life threatening respiratory distress.
The symptoms of nasal congestion, such as ear or hearing issues, loss of smell, facial pain, post nasal drip, headache, itchy nose, itchy eyes, watering eyes, runny nose, sneezing, and stuffed nose are commonly reported by patients to be extremely or moderately bothersome. For surveyed sufferers in the case of edema of the mucous membranes, the symptoms are reported as “well controlled” in 29% of cases, “somewhat controlled” in 41% of cases, and “poorly controlled” in 21% of cases. See, e.g., Manning S C. “Medical management of nasosinus infectious and inflammatory disease.” In: Flint P W, Haughey B H, Lund L J, et al, eds. Cummings Otolaryngology: Head & Neck Surgery. 5th ed. Philadelphia, Pa.: Mosby Elsevier; 2010: chap 50, the contents of which are incorporated herein by reference.
Most patients with nasal congestion report that nasal symptoms have a significant adverse impact on their daily life, a problem not always appreciated by physicians and society in general. Patients have reported that the degree of affliction of associated nasal symptoms, such as reduced productivity, poor concentration, thirst, headache, and tiredness, varies from somewhat troublesome to very troublesome. Other consistent findings among nasal congestion sufferers are high rates of sleep disorders, daytime fatigue, and memory impairment and reduced work productivity.
The changes in the histopathology of the mucous membranes that have been reported for nasal congestion include greater goblet cell hyperplasia, thicker epithelium, changes in the basal membrane and the presence of a diverse range of cells associated with inflammation. There have been several descriptions of the histopathology of nasal membrane inflammation, including metaplasia, pseudo thickening of the basal membrane and infiltration of the mucous membrane by inflammatory cells, such as eosinophils, neutrophils, CD8 T-lymphocytes and macrophages. The cellular and molecular mechanisms of the inflammatory process in the upper airways of patients with nasal congestion have been studied increasingly over the last few decades. However, to the best of the knowledge of the inventor, no studies to date have been conclusive as to treatment protocols.
Nasal congestion is a cardinal symptom of allergic rhinitis (AR), an inflammatory response of the nasal and paranasal mucous membranes. The inflammatory response of the mucous membranes can be attributed to IgE antibodies. The prevalence of AR is increasing worldwide, a trend that has been attributed to a variety of factors, such as changing global climate conditions, improvements in hygiene, changes in diet, and increased obesity. AR, whether atopic or non-atopic, is a risk factor for the development of asthma. Nasal congestion and runny nose were identified as the most irritable symptoms of AR and were the most frequently reported symptom of AR. Accordingly, the alleviation of nasal congestion and runny nose is often a primary goal of AR therapy and management.
It is estimated that prescription only medications for the current management of allergic rhinitis symptoms are used by 12 to 24% of sufferers, whereas over-the-counter (OTC) medicines are estimated to be used by up to 50% of other sufferers of AR. Orban N T, Saleh H, Durham S R. “Allergic and non-allergic rhinitis”. In: Adkinson N F Jr, ed. Middleton's Allergy: Principles and Practice. 7th ed. Philadelphia, Pa.: Mosby Elsevier; 2008: Chap 55, the contents of which are incorporated herein by reference.
Classes of drugs that can be used to treat AR include antihistamines, corticosteroids, mast cell stabilizers, decongestants, nasal anti-cholinergics, and leukotriene receptor antagonists. Intranasal corticosteroids typically provide significantly greater relief of nasal congestion than oral antihistamines. However, the adverse side-effects of corticoids may preclude their widespread use.
None of these prior art methods, drugs, treatments and/or therapies provides an entirely satisfactory solution to the alleviation or treatment of the symptoms or underlying causes of nasal congestion, nasal allergies, allergic rhinitis and other disease conditions of the nasal and paranasal mucous membranes.